Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2d588f58-418d-4ab9-b6cc-de6719532b18
Route
TOPICAL
Published
Effective Date 2012-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C Cetyl Alcohol Dimethicone Glyceryl Monostearate Isopropyl Myristate Polyoxyl 8 Stearate Polyoxyl 100 Stearate Petrolatum Water Sodium Hydroxide Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2008-03-28

Description

Pramoxine hydrochloride 1%

Purpose

external analgesic


Medication Information

Purpose

external analgesic

Description

Pramoxine hydrochloride 1%

Use

for the temporary relief of itching associated with minor skin irritations

Section 42229-5

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma       74146

Warnings

For external use only

Directions
  • To open, squeeze cap tightly and turn pump counter-clockwise.

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor. 

Active Ingredient

Pramoxine hydrochloride 1%

Other Information

Side effects may be reported to 1-888-438-7426

Inactive Ingredients

benzyl alcohol, carbomer 940, cetyl alcohol, dimethicone, glyceryl stearate, isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water, sodium hydroxide, stearic acid

Find more about Sarna!

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

www.sarna-skincare.com

Made in Canada

A099718

Principal Display Panel

NDC 54868-1587-0

Sarna®

SENSITIVE

Pramoxine Hydrochloride 1%

ANTI-ITCH LOTION

Steroid-Free and Fragrance-Free

DERMATOLOGIST Recommended

  • Relieves itching associated with:

DRY, SENSITIVE SKIN

ECZEMA

  • Moisturizing

Net Wt. 7.5 Fl Oz. (222 mL)

A099717

When Using This Product
  • avoid contact with the eyes.
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

Caution -- Do not use in the eyes or nose. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by a physician.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

for the temporary relief of itching associated with minor skin irritations

Section 42229-5 (42229-5)

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma       74146

Purpose

external analgesic

Warnings

For external use only

Directions
  • To open, squeeze cap tightly and turn pump counter-clockwise.

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor. 

Active Ingredient (Active ingredient)

Pramoxine hydrochloride 1%

Other Information

Side effects may be reported to 1-888-438-7426

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carbomer 940, cetyl alcohol, dimethicone, glyceryl stearate, isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water, sodium hydroxide, stearic acid

Find more about Sarna!

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

www.sarna-skincare.com

Made in Canada

A099718

Principal Display Panel

NDC 54868-1587-0

Sarna®

SENSITIVE

Pramoxine Hydrochloride 1%

ANTI-ITCH LOTION

Steroid-Free and Fragrance-Free

DERMATOLOGIST Recommended

  • Relieves itching associated with:

DRY, SENSITIVE SKIN

ECZEMA

  • Moisturizing

Net Wt. 7.5 Fl Oz. (222 mL)

A099717

When Using This Product (When using this product)
  • avoid contact with the eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

Caution -- Do not use in the eyes or nose. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by a physician.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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